What are the responsibilities and job description for the Quality Compliance Specialist position at Intellectt Inc?
Hi,
We have a requirement for Senior Quality Compliance Specialist for one of our medical devices client, If you're interested in this role, you can share your updated resume to narayana@intellectt.com or you can call me at 1 732 769 3774
Role: Sr Quality Compliance Spececialist
Location: Remote role.
Duration: 9 Months on W2
Must work in the PST timezone from 8 AM to 5 PM.
Job Description
We have a requirement for Senior Quality Compliance Specialist for one of our medical devices client, If you're interested in this role, you can share your updated resume to narayana@intellectt.com or you can call me at 1 732 769 3774
Role: Sr Quality Compliance Spececialist
Location: Remote role.
Duration: 9 Months on W2
Must work in the PST timezone from 8 AM to 5 PM.
Job Description
- Managing complaints for transcatheter heart valve (THV) devices.
- Oversight of safety reporting for global complaints across 100 countries.
- Collaboration with counterparts in Japan and Europe.
- Reviewing adverse events from ongoing clinical studies.
- Familiarity with Microsoft Office suite, Salesforce, and Power BI preferred.
- Assessing the reportability of complaints and investigating incidents with medical professionals; Coordinating with field representatives and nurses to gather clinical insights.
- Generating documentation for investigations and submitting Medical Device Reports (MDRs) to regulatory agencies; Managing multiple projects and meeting regulatory deadlines.
- The training period for this position typically lasts about four months before an individual can begin handling complaints or signing off on complaint processes.
- During this time, they undergo extensive training on various aspects, including the company's quality management system, internal processes, different device malfunctions and adverse events, and regulatory requirements.
- Additionally, they may receive training on specific devices and their functionalities, as well as clinical studies and associated adverse event reporting.
- This comprehensive training ensures that they are fully equipped to handle the responsibilities of the role effectively.
- Bachelor's degree in science, engineering, or related field preferred.
- Minimum of five years of experience in complaint handling for medical devices.
- Knowledge of cardiology and medical device reporting regulations is highly desirable.
- Experience with ATQ database for complaint management.
- Experience in complaint handling for medical devices.
- Proficiency in complaint handling and medical device reporting.
- Proficiency in medical devices reporting to the FDA.
- Familiarity with medical terminology, particularly in cardiology.
- Ability to adapt to changing regulations and processes.
- Initial interview with Hiring Manager, followed by a panel video interview consisting of 4 to 5 members.
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